CFR section
21 CFR 58.113(a)(2): Mixtures of articles with carriers
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart F-Test and Control Articles
Key facts
| Citation | 21 CFR 58.113(a)(2) |
|---|---|
| Section | Mixtures of articles with carriers |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart F-Test and Control Articles |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | (2) To determine the stability of the test and control articles in the mixture as required by the conditions of the study either: (i) Before study initiation, or (ii) Concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture. |
At a glance
- 1–9 Inspections citing this section
- 1–9 Warning letters citing this section
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.